510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
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978
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2199
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2050
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126
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99
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8
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471
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966
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436
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279
Orthopedic
2949
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52
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515
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2454
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
280
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Sol-Millennium Medical, Inc.
Medical Device Manufacturer
·
US , Lawrenceville , GA
Sol-Millennium Medical, Inc. - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 2014
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sol-Millennium Medical, Inc.
Chemistry
✕
1
devices
1-1 of 1
Filters
Cleared
May 19, 2017
Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
K163073
·
JKA
Chemistry
·
198d
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12
General Hospital
11
Chemistry
1